[Remote] Senior Regulatory Affairs Manager (Labeling)- FSP at Thermo Fisher Scientific

Germany

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Life SciencesIndustries

Requirements

Strong organizational, technical, and regulatory expertise to manage complex global labeling operations within a matrixed environment
Experience with DLS or equivalent and CCDS documentation
Knowledge of international regulatory standards, country-specific requirements, FDA-508 compliance, EU Clinical Trial Regulation (CTR), and other regional regulations

Responsibilities

Coordinate readability testing, translations, and linguistic reviews for foundational markets (EU, CH, DE)
Manage the preparation, review, and upload of approved labels to internal systems (Documentum, Weblabel, intranet) and external platforms (HA, ePIL)
Dispatch CCDS, foundational labels, and multi-market manuscripts to dependent markets, collaborators, and partners
Coordinate and perform data entry for labeling systems (Trackwise, Veeva) and maintain labeling records
Maintain and update Company Core Data Sheet (CCDS), US Prescribing Information (USPI), and EU Summary of Product Characteristics (SmPC)
Lead Global Labeling Committee (GLC) evaluations and handle exceptions between CCDS and regional labels
Support label content creation, including development of DLS or equivalent experience and CCDS documentation
Assemble materials for the Labeling Review Committee (LRC) and Global Labeling Committee (GLC), maintaining accurate records of decisions and minutes
Manage global labeling compliance activities, including quality control, FDA-508 compliance, and annual reporting requirements (US drug listing and NDC assignments)
Manage impact evaluations for technical and global labeling modifications
Ensure adherence to country-specific regulatory requirements for labeling, submissions, and artwork approvals
Prepare change control documentation and deviation reports for foundational and non-foundational markets
Manage Health Authority (HA) requests, RFIs, and label negotiations
Provide regulatory assistance for advertising, promotion, and medical education materials to ensure alignment with approved labeling and regional requirements
Collaborate with Medical Affairs, Legal, and Commercial teams to review and approve promotional and non-promotional materials
Manage Standard Operating Procedures (SOPs) and electronic review systems related to labeling and promotional review
Provide strategic input to therapeutic area teams and influence external labeling landscapes through competitive intelligence and regulatory insight
Act as key partner to GRA Regions, Regulatory CMC, and Supply Chain to ensure accurate and timely implementation of labeling decisions
Develop and coordinate global Clinical Trial Authorization (CTA) submission strategy
Act as the regulatory interface between labeling, clinical operations, and global health authorities
Ensure adherence to EU Clinical Trial Regulation (CTR) and other regional regulatory requirements

Skills

Regulatory Affairs

Global Labeling

CCDS

USPI

Documentum

Weblabel

Trackwise

Veeva

Readability Testing

Translations

Linguistic Reviews

Regulatory Compliance

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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